Text Size

Wound Interdisciplinary Teams (WIT): A Community- Based Pragmatic Randomized Controlled Trial

This study is currently recruiting participants.
Verified May 2013 by University of Toronto
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Murray Krahn, University of Toronto
ClinicalTrials.gov Identifier:
NCT01348841
First received: May 4, 2011
Last updated: May 10, 2013
Last verified: May 2013
History of Changes
  Purpose

Wounds that are slow to heal (chronic) may be managed in different ways. In Ontario, care in the community for most of these is coordinated by the local Community Care Access Centre (CCAC). One or more health professionals might deliver treatment, individually or as part of a wound care team, with different members having different kinds of training (interdisciplinary team), which may or may not include wound care. Community treatment by interdisciplinary teams has been shown to be more effective and cost-effective for some long-standing health problems, but further scientific evidence is needed to determine if this is also true for chronic wounds.

This study compares the usual way chronic wounds are being managed in the community with a so-called "intermediate care" approach. In this study, intermediate care will involve health service providers following certain agreed-upon steps (evidence-based best practice) from first contact with the client through assessment, treatment, and on to referral to a hospital specialty wound care team, if needed.


Condition Intervention Phase
Wound of Skin
 Other: Systematic referral to MDWCT and comprehensive primary care
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Wound Interdisciplinary Teams (WIT): A Community- Based Pragmatic Randomized Controlled Trial

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Time to Healing [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The primary clinical outcome measure will be time to healing, ascertained by digital wound photography using computer planimetry for wound measurement.


Secondary Outcome Measures:
  • proportion of wound healed [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    proportion of wounds healed at 6 mths and the rate of wound healing(cm2/week).

  • Wound recurrence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Wound recurrence within the study period.

  • time to discontinuation of wound service [ Time Frame: 1 years ] [ Designated as safety issue: No ]
    Time to discontinuation of wound services within the CCAC and interdisciplinary teams.

  • Health Related Quality of Life (HRQOL) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Health related quality of life.

  • client satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Satisfaction with care.

  • cost and resource use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    cost and resource use of wound care provided


Estimated Enrollment: 450
Study Start Date: May 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Arm
Usual care is care as currently delivered to clients with chronic wounds in the community.
Experimental: Intervention Arm

Systematic referral to MDWCT and comprehensive primary care:

Intervention consists of systematic referral to MDWCT in conjunction with comprehensive primary care.Systematic referral to, and follow up, by MDWCTs, co-ordinated by the CM, will occur.There will be immediate referral to the MDWCT of clients with :1/ diabetic lower extremity ulcers,2/peripheral neuropathy, charcot changes,3/wound present longer than 4 mths. ,4/ Ankle Brachial Index less than 0.6, non-diabetics, and not being seen by a vascular surgeon. Subsequent referral to MDWCT will occur if less than 30% healing by week 4.

 Other: Systematic referral to MDWCT and comprehensive primary care
Systematic referral to, and follow up, by Multi-Disciplinary Wound Care Teams (MDWCTs), co-ordinated by the Case Manager (CM), will occur.There will be immediate referral to the MDWCT of clients with :1/ diabetic lower extremity ulcers,2/peripheral neuropathy, charcot changes,3/wound present longer than 4 mths. ,4/ Ankle Brachial Index less than 0.6, non-diabetics, and not being seen by a vascular surgeon. Subsequent referral to MDWCT will occur if less than 30% healing by week 4.
Other Name: systematic expedited referral to MDWCTs

Detailed Description:

For certain types of chronic illness, planning case management and providing care according to evidence-based guidelines (published methods that have been supported scientifically) results in better clinical outcomes and better cost-effectiveness. Wound management by interdisciplinary teams may have these advantages in both the community primary care setting and the hospital specialized care setting. Systematic review of the literature indicated that the evidence was incomplete to support implementation of an intermediate care model for community management of chronic wounds. Therefore, the Ontario Health Technology Advisory Committee recommended that a field evaluation be conducted to provide stronger evidence about the relative effectiveness, cost-effectiveness and feasibility of managing chronic wounds in the community using both standardized, comprehensive primary care and a systematic method of referral to a specialty, multidisciplinary team based in a hospital

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (>18 years of age) client with eligible wound type (not surgical, malignant or burns) referred to the Toronto Central CCAC for wound management.
  • Client (or substitute decision maker) provides written, informed consent.
  • Someone in client's home (or substitute decision maker) must be able to speak English.

Exclusion Criteria:

  • Surgical wounds
  • Burns
  • Malignant wounds
  • Clients who are designated palliative on CCAC referral form
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348841

Contacts
Contact: Josephine Wong, MD 416-978-7913 josephine.wong@theta.utoronto.ca
Contact: Valeria Rac, MD, PhD 416-946-3706 valeria.rac@theta.utoronto.ca

Locations
Canada, Ontario
THETA Collaborative Recruiting
Toronto, Ontario, Canada, M5S 3M2
Contact: Josephine Wong, MD     416-978-7913     josephine.wong@theta.utoronto.ca    
Sponsors and Collaborators
University of Toronto
Ontario Ministry of Health and Long Term Care
Investigators
Principal Investigator: Murray Krahn, PhD, MD Director
  More Information

Additional Information:
Ontario Health Technology Advisory Committee (OHTAC) Recommendation: Specialized Multidisciplinary Community-Based Care, 2009.  This link exits the ClinicalTrials.gov site
Medical Advisory Secretariat. Multidisciplinary Care Community-Based Care for Chronic Wound Management: An Evidence-Based Analysis Ontario Ministry of Health and Long-Term Care, 2009.  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Murray Krahn, Director, THETA, University of Toronto
ClinicalTrials.gov Identifier: NCT01348841     History of Changes
Other Study ID Numbers: 25973
Study First Received: May 4, 2011
Last Updated: May 10, 2013
Health Authority: Canada: Ministry of Health & Long Term Care, Ontario

Keywords provided by University of Toronto:
community wound care
systematic wound team referral
Advanced in-home nurse wound training

ClinicalTrials.gov processed this record on May 16, 2013